MERLIN pre-clinical research and development

  • Research type

    Research Study

  • Full title

    MEsenchymal Stem Cells to Reduce Liver INflamation (MERLIN), pre-clinical development project

  • IRAS ID

    146580

  • Contact name

    Phil Newsome

  • Contact email

    p.n.newsome@bham.ac.uk

  • Research summary

    The MERLIN collaborative project has been funded by an EU FP7 grant. The overarching aims of this project are to establish the action of Mesenchymal Stromal Cells (MSC), a type of human cell that is derived from human bone marrow, in an archetypal inflammatory liver disease primary sclerosing cholangitis (PSC) in order to develop an entirely new treatment option for patients, presently facing a disease devoid of effective medical care. MERLIN will deliver a new type of MSC cell manufacturing technology, which is a radical improvement in terms of cell purity and compliance with emerging regulations. MERLIN will investigate the effects and mechanism of action of these new types of MSC in inflammatory liver disease, whilst establishing potency assays in mice. Parallel research will identify the most effective strategies for maximising the life span of MSC cells as well as trying to understand how they move around inside relevant disease models in mice once infused. This will give information relevant to the design of a clinical trial.

    The long term goal of the MERLIN project is the treatment of patients with PSC under a Phase 2a randomised controlled clinical trial. This research protocol and ethics application are focussed on the pre-clinical development stages necessary to deliver the clinical therapy detailed above. No samples/cells/tissues obtained under these ethics will be used in patients. Separate ethics for the clinical trial stages will be submitted at a later date.

  • REC name

    West Midlands - Edgbaston Research Ethics Committee

  • REC reference

    14/WM/1022

  • Date of REC Opinion

    30 Jun 2014

  • REC opinion

    Favourable Opinion